Physical InactivityAI-ACTIV-ENCT05779696
Artificial Intelligence and Physical Activity Among People From Ethnic Minority Groups
An observational study of Physical Inactivity, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Despite the high interest in physical activity, many individuals lack the necessary experience in being active and therefore have low levels of knowledge and confidence to become and stay active. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- No-intervention
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: We aim to recruit a range of people from different ethnic minority groups - we are interested in a diverse sample of participants with a wide-ranging view on the use of digital-health based interventions and AI.
Who may be able to join
- Participants must be over 18 years old;
- Participants must be able to a computer/mobile device to access the survey or video conference software (Zoom, as used by the Centre of Ethnic Health Research)
- Participants can come from a range of cultural communities and religious groups;
- Participants do not need to have any prior knowledge to participate in the virtual focus groups or the survey.
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Thomas Wilkinson
Leicester, Leicestershire, LE1 7RH
Thomas Wilkinson, 07538494193, tjw26@leicester.ac.uk
tjw26@leicester.ac.uk
About this study
Official title: Understanding and Identifying the Potential of Artificial Intelligence Powered Digital Physical Activity and Lifestyle Interventions Among People From Ethnic Minority Groups: a Mixed Methods Study
Despite the high interest in physical activity, many individuals lack the necessary experience in being active and therefore have low levels of knowledge and confidence to become and stay active. For effective lifestyle changes to occur, information must be tailored to the individual's health, goals, motivations, and overall ability. Lifestyle interventions, for example those designed to increase physical activity, are only effective when adapted to the physical, social, and psychological needs of the patient and progressed at rate appropriate for their development by specialist health professional. In the context of ethnic minority health, information must also be culturally adapted, sensitive to religious needs, and accessible to those where English is not proficient. Behavioural digital health interventions have been moderately successful in increasing physical activity, although opportunities for further improvement remain to be discussed. New technologies involving the use of artificial intelligence (AI) are growing, and allow the dissemination of individualised and tailored advice and information. Whilst a few AI-driven physical activity-based applications exist, they are not widely used, particularly amongst people from ethnic minority groups where both physical activity and digital health literacy is poor. Research has identified that whilst many people would be receptive to using health chatbots, hesitancy regarding this technology is likely to compromise engagement. In particular, user perspectives, motivation and capabilities need to be taken into account when developing and assessing the effectiveness of health chatbots. Guidance suggests that developing health chatbots should focus on issues of digital literacy, linguistic and cultural issues, privacy concerns, and personalization. As such, any development needs to involve user-driven co-creation techniques and involving community partners to increase the probability that it will ultimately be effective.
Aims
Read more
Aim 1 Gain a new understanding of barriers and facilitators to digital physical activity interventions and AI-delivered healthcare in people from ethnic minority groups through an online survey
Aim 2 To conduct a series of focus groups to explore participants understanding and identifying barriers and facilitators to digital physical activity interventions. In particular to:
i)Better understand general barriers and facilitators (focus on access and provision of education, and physical, environmental, cultural and psycho-social barriers) to physical activity; ii)Explore current and future usage of digital-based resources to facilitate physical activity behaviour; iii)Investigate views of use of AI in digital-based healthcare applications (e.g., trust in such applications)
- Conditions
- Physical Inactivity
- Being tested
- No-intervention
- Keywords
- Physical activity, Artificial intelligence, Ethnic health
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-interventionOther
This is a non-intervention study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | We will recruit a diverse range of participants to take part and therefore have a limited inclusion/exclusion criteria. Participants must be over 18 years old and be able to a computer/mobile device to access the survey or video conference software (Zoom, as used by the Centre of Ethnic Health Research). Participants can come from a range of cultural communities and religious groups. Participants do not need to have any prior knowledge to participate in the virtual focus groups or the survey. Receives: Other: No-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feelings towards chatbots and artificial intelligence
Bespoke questions via online survey. Questions answered on a Likert scale between 1 and 7; with 1 being 'disagree completely' and 7 being 'agree completely'
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Wilkinson, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779696
- Sponsor's protocol ID
- 39522
- Acronym
- AI-ACTIV-E
- Status last verified
- May 2023
- First submitted
- 9 Mar 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Identifying the Potential of Artificial Intelligence Powered Digital Physical Activity and Lifestyle Interventions Among People From Ethnic Minority Groups: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05779696
- Acronym / sponsor ID
- AI-ACTIV-E / 39522
- Conditions
- Physical Inactivity
- Keywords
- Physical activity, Artificial intelligence, Ethnic health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the high interest in physical activity, many individuals lack the necessary experience in being active and therefore have low levels of knowledge and confidence to become and stay active. For effective lifestyle changes to occur, information must be tailored to the individual's health, goals, motivations, and overall ability. Lifestyle interventions, for example those designed to increase physical activity, are only effective when adapted to the physical, social, and psychological needs of the patient and progressed at rate appropriate for their development by specialist health professional. In the context of ethnic minority health, information must also be culturally adapted, sensitive to religious needs, and accessible to those where English is not proficient. Behavioural digital health interventions have been moderately successful in increasing physical activity, although opportunities for further improvement remain to be discussed. New technologies involving the use of artificial intelligence (AI) are growing, and allow the dissemination of individualised and tailored advice and information. Whilst a few AI-driven physical activity-based applications exist, they are not widely used, particularly amongst people from ethnic minority groups where both physical activity and digital health literacy is poor. Research has identified that whilst many people would be receptive to using health chatbots, hesitancy regarding this technology is likely to compromise engagement. In particular, user perspectives, motivation and capabilities need to be taken into account when developing and assessing the effectiveness of health chatbots. Guidance suggests that developing health chatbots should focus on issues of digital literacy, linguistic and cultural issues, privacy concerns, and personalization. As such, any development needs to involve user-driven co-creation techniques and involving community partners to increase the probability that it will ultimately be effective.
Aims
Aim 1 Gain a new understanding of barriers and facilitators to digital physical activity interventions and AI-delivered healthcare in people from ethnic minority groups through an online survey
Aim 2 To conduct a series of focus groups to explore participants understanding and identifying barriers and facilitators to digital physical activity interventions. In particular to:
i)Better understand general barriers and facilitators (focus on access and provision of education, and physical, environmental, cultural and psycho-social barriers) to physical activity; ii)Explore current and future usage of digital-based resources to facilitate physical activity behaviour; iii)Investigate views of use of AI in digital-based healthcare applications (e.g., trust in such applications)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No-interventionWe will recruit a diverse range of participants to take part and therefore have a limited inclusion/exclusion criteria. Participants must be over 18 years old and be able to a computer/mobile device to access the survey or video conference software (Zoom, as used by the Centre of Ethnic Health Research). Participants can come from a range of cultural communities and religious groups. Participants do not need to have any prior knowledge to participate in the virtual focus groups or the survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We aim to recruit a range of people from different ethnic minority groups - we are interested in a diverse sample of participants with a wide-ranging view on the use of digital-health based interventions and AI.
Key inclusion criteria (4 listed)
- Participants must be over 18 years old;
- Participants must be able to a computer/mobile device to access the survey or video conference software (Zoom, as used by the Centre of Ethnic Health Research)
- Participants can come from a range of cultural communities and religious groups;
- Participants do not need to have any prior knowledge to participate in the virtual focus groups or the survey.
Key exclusion criteria (1 listed)
- No specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-interventionThis is a non-intervention study. | Other | Group 1 |
Primary outcome
Feelings towards chatbots and artificial intelligence
Time frame: 12 months
Bespoke questions via online survey. Questions answered on a Likert scale between 1 and 7; with 1 being 'disagree completely' and 7 being 'agree completely'
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Webpage for studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Inactivity, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feelings towards chatbots and artificial intelligence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.